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NCT05403476 · ClinicalTrials.gov registry record · Phase 2

A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)

A Phase 2 study, sponsored by Ferring Pharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
4
Enrollment target

NCT05403476: Clinical Trial Phase 2 study, sponsored by Ferring Pharmaceuticals.

NCT05403476 is a Phase 2 study that was terminated before completion, run by Ferring Pharmaceuticals. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05403476, a Phase 2 study, was terminated before completion, sponsored by Ferring Pharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
4 participants
Enrollment target

Study Summary

The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed in their female partners in comparison to placebo (inactive treatment). For more information, please visit the trial's website www.adamclinicaltrial.com (only applicable in the US).

Primary Outcome

Vital pregnancy is documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound.

Interventions

  • DRUG Placebo
  • DRUG FE 999049

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2022-08-16
Est. Completion 2024-10-23
Phase Phase 2
Ferring Pharmaceuticals

83 total trials

Why NCT05403476 stopped before completion

NCT05403476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05403476 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05403476 about?

NCT05403476 is a clinical study titled "A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)". The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed ...

What is the current status of trial NCT05403476?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2022-08-16. Estimated completion is 2024-10-23.

What interventions are being tested in trial NCT05403476?

The interventions under investigation include: Placebo (DRUG), FE 999049 (DRUG).

Who is sponsoring clinical trial NCT05403476?

This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05403476's enrollment target sits among peer trials

4 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05403476, the US trial registry maintained by the National Library of Medicine. NCT05403476 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.